The Bleeding Edge

PB Deputy Managing Director Dan Jones writes…


Dan Jones

Dan Jones

Some of you may have already watched the new Netflix documentary on medical devices – the Bleeding Edge. The programme highlights the plight facing patients who have suffered an adverse event following the implantation of a medical device, rightly highlighting the human impact of devices and detailing the impact on people’s lives when things go wrong.

The documentary raises a number of issues around the regulation of medical devices, and whilst the documentary looks at American regulators, it raises a number of issues that are also being addressed by European Regulators. Questions around how devices are brought to market have been discussed by regulators, politicians and the press for many years.

The documentary compares the regulation of devices to that of pharmaceutical products. Whilst on the surface this comparison might seem reasonable, moving medical device regulation towards a pharmaceutical system is unlikely to benefit patients. There are a number of reasons for this. Firstly, the ethical concerns. Blind randomised clinical trials require the use of placebo. There is no ethical way of creating a placebo group when dealing with medical implants.

Secondly, medical devices rely far more on the human element than pharmaceuticals. A skilled clinician implanting a complex device, in trial conditions, would likely have a high success rate. In the real world, with less skilled clinicians, not working under trial conditions would be unlikely to achieve as high a success rate.

Finally, the iterative development of medical devices means data from 10-15 years ago is unlikely to be representative of the current device. As devices are used, developers gain feedback from surgeons and users and improve the device. Compare this to other technology, such as your mobile phone – most of us update to an improved model every couple of years. The same is true of devices. If you were to look at data from decades ago, in trials conducted as the device was brand new and surgeons were less skilled in its use, you would likely get a different result to the use of real world data from registries and more recent trials.

The recent update of the Medical Device Regulations at EU level has greatly strengthened the way devices are brought on to the market. There are still some areas where improvements could be made, both by regulators and the NHS.

Improve Market entry – Beyond Compliance

UK regulators have actually led the way in developing an improved system for the introduction of medical devices. Following the issues related to the metal-on-metal hip implants, industry, clinicians and UK regulators worked together to develop a new system for putting orthopaedic products on the market. This system is known as ‘Beyond Compliance’. Beyond Compliance sets a maximum number of patients that can receive a new implant in years 1-5. Following this period there is an assessment of data, and assuming the device is proven to be safe and effective it can then be used more widely.

This mechanism should be developed for more areas. Regulators, industry and clinicians should work together to develop similar methods in area where complex medical devices are implanted in the body and remain there for a number of years.




Better use of registries

The metal-on-metal hip issue was initially identified using registry data in Australia. Registries are the only effective way of tracking devices and gaining a comprehensive view on their long term effectiveness.

A registry is simply a record of which medical devices have been implanted into which patient, with the potential for data on long term follow up, where possible. Very few medical implants are included in mandatory registers. The National Joint Registry has been in place for 15 years and provides near comprehensive data on orthopaedic implants in the UK. Registries would help improve patient safety and the development of new treatments.

The NHS should work with clinical societies to develop registries.

Legally enforced minimum levels of procedures per year

Implanting a permanent medical device in a patient is a complex process that requires a high skill level from a clinician. The likelihood of a successful outcome is more dependent on the ability of your surgeon than the actual device. In order to implant a device surgeons will have to undergo training and implant a minimum number, which varies between devices, before they are able to implant without the support of a fully trained surgeon.

Following this, however, the rules on how many procedures are carried out each year vary and are not always strictly set down as part of regulatory compliance. The data shows that surgeons performing high volumes of a procedure get better outcomes. The GIRFT report on Orthopaedics is clear on this – highlighting the fact that “24.1% of surgeons were performing ten or fewer hip replacements a year.”

Professional societies will often have guidelines on the minimum numbers of procedures surgeons should be carrying out each year. These guidelines should be made mandatory, with surgeons who fail to undertake the minimum number of treatments in a given year receiving additional training before undertaking a procedure unsupervised.

Mandatory reporting of negative events – to regulators, industry and clinicians

Manufacturers are required to report adverse events to their regulator. Improved reporting of adverse events would allow regulators to identify any faulty products and recall them from the market more quickly.

Any clinician using a medical device should also be required, by law, to report all adverse events. Clinicians are more likely to be aware of any events than manufacturers and are better placed to help identify any patterns.

This process should also include a comprehensive feedback loop, where all information on adverse events is shared with clinicians and industry.

Device information sheets

Most of us will know someone who has some form of medical implant – a grandparent with hip replacement, for example. This device could remain inside them for twenty years or more. Now ask them who made the device or what the product is called. You’d likely get a blank stare. Most people will spend more time choosing their bathroom fittings than they will learning about a medical device that will sit inside them for years.

As the PIP breast implant scandal showed, if you don’t have information on what device is inside you, you can be left scared and confused if a major recall takes place and you are not sure of whether or not you have that product.

Anyone who receives a medical device implant should be given a Device Information Sheet. This should set out the device name, the brand name, the manufacturer, the batch number, the place of manufacture, the name of the surgeon who implanted, and the location of the implantation. All of this information could be crucial to patients in the future and it sure therefore be standard practice to deliver this to them.

In conclusion, many of the ideas set out above cannot be done by regulators alone. They will require the support and input of manufacturers, clinicians and clinical societies, many of whom are already engaging on these issues. What is required is clear support from NHS leaders and Government Ministers to empower regulators to go out and implement the measures above and work with industry and clinicians to ensure we have the appropriate mechanisms in place. With that should also come the appropriate funding to ensure that we have a fit for purpose regulatory regime that delivers the right products to patients at the right time.